CN102245210A - 有恒定高暴露水平的奥曲肽贮库制剂 - Google Patents

有恒定高暴露水平的奥曲肽贮库制剂 Download PDF

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Publication number
CN102245210A
CN102245210A CN2009801503147A CN200980150314A CN102245210A CN 102245210 A CN102245210 A CN 102245210A CN 2009801503147 A CN2009801503147 A CN 2009801503147A CN 200980150314 A CN200980150314 A CN 200980150314A CN 102245210 A CN102245210 A CN 102245210A
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CN
China
Prior art keywords
pharmaceutical composition
plga
octreotide
microgranule
sustained release
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN2009801503147A
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English (en)
Chinese (zh)
Inventor
M·阿尔海姆
H·彼得森
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Novartis AG
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Novartis AG
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Publication date
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=40520410&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CN102245210(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novartis AG filed Critical Novartis AG
Priority to CN201510542720.5A priority Critical patent/CN105233251A/zh
Priority to CN201510542237.7A priority patent/CN105031607A/zh
Publication of CN102245210A publication Critical patent/CN102245210A/zh
Pending legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/31—Somatostatins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12—Antidiarrhoeals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • A61P5/08—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH for decreasing, blocking or antagonising the activity of the anterior pituitary hormones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Dermatology (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Diabetes (AREA)
  • Cardiology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CN2009801503147A 2008-12-15 2009-12-14 有恒定高暴露水平的奥曲肽贮库制剂 Pending CN102245210A (zh)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN201510542720.5A CN105233251A (zh) 2008-12-15 2009-12-14 有恒定高暴露水平的奥曲肽贮库制剂
CN201510542237.7A CN105031607A (zh) 2008-12-15 2009-12-14 有恒定高暴露水平的奥曲肽贮库制剂

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP08171712 2008-12-15
EP08171712.6 2008-12-15
PCT/EP2009/067049 WO2010079047A2 (en) 2008-12-15 2009-12-14 Octreotide depot formulation with constantly high exposure levels

Related Child Applications (2)

Application Number Title Priority Date Filing Date
CN201510542237.7A Division CN105031607A (zh) 2008-12-15 2009-12-14 有恒定高暴露水平的奥曲肽贮库制剂
CN201510542720.5A Division CN105233251A (zh) 2008-12-15 2009-12-14 有恒定高暴露水平的奥曲肽贮库制剂

Publications (1)

Publication Number Publication Date
CN102245210A true CN102245210A (zh) 2011-11-16

Family

ID=40520410

Family Applications (3)

Application Number Title Priority Date Filing Date
CN2009801503147A Pending CN102245210A (zh) 2008-12-15 2009-12-14 有恒定高暴露水平的奥曲肽贮库制剂
CN201510542720.5A Pending CN105233251A (zh) 2008-12-15 2009-12-14 有恒定高暴露水平的奥曲肽贮库制剂
CN201510542237.7A Pending CN105031607A (zh) 2008-12-15 2009-12-14 有恒定高暴露水平的奥曲肽贮库制剂

Family Applications After (2)

Application Number Title Priority Date Filing Date
CN201510542720.5A Pending CN105233251A (zh) 2008-12-15 2009-12-14 有恒定高暴露水平的奥曲肽贮库制剂
CN201510542237.7A Pending CN105031607A (zh) 2008-12-15 2009-12-14 有恒定高暴露水平的奥曲肽贮库制剂

Country Status (25)

Country Link
US (10) US20100151033A1 (https=)
EP (1) EP2376070B1 (https=)
JP (1) JP5721635B2 (https=)
KR (1) KR101708517B1 (https=)
CN (3) CN102245210A (https=)
AR (1) AR074603A1 (https=)
AU (1) AU2009336718B9 (https=)
BR (1) BRPI0922607B1 (https=)
CA (1) CA2746968C (https=)
CL (1) CL2011001438A1 (https=)
CO (1) CO6382109A2 (https=)
EC (1) ECSP11011199A (https=)
ES (1) ES2602614T3 (https=)
IL (1) IL213034A (https=)
MA (1) MA32964B1 (https=)
MX (1) MX2011006335A (https=)
MY (1) MY159789A (https=)
NZ (1) NZ592998A (https=)
PE (1) PE20110876A1 (https=)
PL (1) PL2376070T3 (https=)
PT (1) PT2376070T (https=)
RU (1) RU2526822C2 (https=)
SG (1) SG171255A1 (https=)
TN (1) TN2011000261A1 (https=)
WO (1) WO2010079047A2 (https=)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017186077A1 (zh) 2016-04-26 2017-11-02 广州帝奇医药技术有限公司 一种缓释微粒的制备方法
CN111712228A (zh) * 2017-09-15 2020-09-25 奥叙拉尔有限公司 眼科药物组合物

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101814186B1 (ko) 2008-09-17 2018-03-14 키아스마 인코포레이티드 약제학적 조성물 및 연관된 투여방법
TWI636799B (zh) * 2012-05-14 2018-10-01 日商帝人股份有限公司 滅菌組成物
BR112016022550B1 (pt) * 2014-03-31 2023-03-28 Pharmathen S.A Processo para a preparação de microesferas de plga de acetato de octreotida
AU2015360485B2 (en) 2014-12-10 2020-06-25 Amryt Endo, Inc. Oral octreotide administered in combination with other therapeutic agents
WO2016126830A1 (en) 2015-02-03 2016-08-11 Chiasma Inc. Method of treating diseases
KR102142026B1 (ko) * 2017-05-31 2020-08-06 주식회사 대웅제약 방출제어가 용이한 서방성 약물 미립자의 제조방법
MX2022002980A (es) 2019-09-16 2022-04-06 Amgen Inc Metodo para la esterilizacion externa de un dispositivo de suministro de farmacos.
US11141457B1 (en) 2020-12-28 2021-10-12 Amryt Endo, Inc. Oral octreotide therapy and contraceptive methods

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PH30995A (en) * 1989-07-07 1997-12-23 Novartis Inc Sustained release formulations of water soluble peptides.
GB9513224D0 (en) * 1995-06-29 1995-09-06 Sandoz Ltd Organic compounds
RU2355385C2 (ru) * 2002-11-06 2009-05-20 Алза Корпорейшн Композиции пролонгированного действия с контролируемым высвобождением
US20040097419A1 (en) * 2002-11-19 2004-05-20 Holger Petersen Organic compounds
MY158342A (en) * 2003-11-14 2016-09-30 Novartis Ag Pharmaceutical composition
GB0326602D0 (en) * 2003-11-14 2003-12-17 Novartis Ag Organic compounds
US7456254B2 (en) * 2004-04-15 2008-11-25 Alkermes, Inc. Polymer-based sustained release device
JP2008524235A (ja) * 2004-12-15 2008-07-10 キューエルティー ユーエスエー，インコーポレイテッド． オクトレオチド化合物の徐放性送達処方物
ES2755032T3 (es) * 2005-12-22 2020-04-21 Novartis Ag Formulación de liberación sostenida que comprende octreótido y dos o más polímeros de poliláctido-co-glicólido

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017186077A1 (zh) 2016-04-26 2017-11-02 广州帝奇医药技术有限公司 一种缓释微粒的制备方法
CN111712228A (zh) * 2017-09-15 2020-09-25 奥叙拉尔有限公司 眼科药物组合物
CN111712228B (zh) * 2017-09-15 2024-05-07 奥叙拉尔有限公司 眼科药物组合物

Also Published As

Publication number Publication date
PE20110876A1 (es) 2011-12-21
NZ592998A (en) 2013-02-22
WO2010079047A2 (en) 2010-07-15
ECSP11011199A (es) 2011-08-31
BRPI0922607B1 (pt) 2019-11-05
SG171255A1 (en) 2011-07-28
JP2012512147A (ja) 2012-05-31
WO2010079047A3 (en) 2010-09-16
CL2011001438A1 (es) 2011-11-04
ES2602614T3 (es) 2017-02-21
US20110262545A1 (en) 2011-10-27
MY159789A (en) 2017-01-31
US20240082148A1 (en) 2024-03-14
MX2011006335A (es) 2011-07-13
TN2011000261A1 (en) 2012-12-17
MA32964B1 (fr) 2012-01-02
EP2376070B1 (en) 2016-08-10
BRPI0922607A2 (pt) 2015-12-22
CN105031607A (zh) 2015-11-11
CA2746968C (en) 2016-10-04
US20100151033A1 (en) 2010-06-17
AU2009336718B9 (en) 2014-04-03
US20170143791A1 (en) 2017-05-25
AU2009336718A1 (en) 2011-06-30
PL2376070T3 (pl) 2017-04-28
US20140363513A1 (en) 2014-12-11
RU2526822C2 (ru) 2014-08-27
IL213034A (en) 2017-04-30
PT2376070T (pt) 2016-11-16
CN105233251A (zh) 2016-01-13
AR074603A1 (es) 2011-01-26
EP2376070A2 (en) 2011-10-19
US20190209462A1 (en) 2019-07-11
US20160089336A1 (en) 2016-03-31
US20180036230A1 (en) 2018-02-08
CA2746968A1 (en) 2010-07-15
IL213034A0 (en) 2011-07-31
CO6382109A2 (es) 2012-02-15
US20210161806A1 (en) 2021-06-03
KR101708517B1 (ko) 2017-02-20
KR20110104042A (ko) 2011-09-21
US20250205147A1 (en) 2025-06-26
RU2011128538A (ru) 2013-01-20
HK1159505A1 (zh) 2012-08-03
AU2009336718B2 (en) 2014-01-30
JP5721635B2 (ja) 2015-05-20

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Application publication date: 20111116